Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: June 21, 2007
Last updated: August 31, 2007
Last verified: August 2007
The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Fenofibrate 80 mg and metformin 1000 mg (fixed combination)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter Trial Assessing the Acceptability of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Patients With Type 2 Diabetes and Dyslipidemia

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Enrollment: 29
Study Start Date: March 2007

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients aged from 20 to 80 years (at inclusion visit).
  2. Type 2 diabetes treated with a stable dose of metformin for a minimum of 3 months either alone or in combination with another oral hypoglycaemic agent.
  3. Dyslipidemia treated with 160 mg fenofibrate (or bioequivalent formulations) for a minimum of 3 months either alone or in combination with a statin.
  4. And having signed a written informed consent.-

Exclusion Criteria:

  1. Known Type 1 Diabetes, uncontrolled type 2 diabetes [HbA1c > 9.5 %, Fasting plasma glucose (FPG) > 240 mg/dL (> 13.4 mmol/L) on the last performed blood sample (within the last 3 months)].
  2. TG > 500 mg/dL (> 5.65 mmol/L) on the last performed blood sample (within the last 3 months).
  3. Women who are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy) or not using adequate contraceptive methods (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide) or not postmenopausal (> 1 year since their last menstrual period).
  4. Pregnant or lactating women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00490178

Site 3
Marseille, France
Site 1
Nantes, France
Site 2
Tours, France
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information Identifier: NCT00490178     History of Changes
Other Study ID Numbers: C LF23-0121 06 02  2006-002848-28 
Study First Received: June 21, 2007
Last Updated: August 31, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Solvay Pharmaceuticals:
Type II diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016